Container, system and method for providing a solution

ABSTRACT

A container ( 10 ) comprising a plurality of compartments (A, B, C) separated by compartment dividers ( 6 ), and an inlet connector ( 3 ) for receiving a liquid via a connection tube ( 2 ). The compartment dividers rupture when a sufficient pressure is applied by a liquid or gas introduced into the container ( 10 ) through the inlet connector ( 3 ). Some of the compartments comprise powder, which dissolves at the introduction of liquid into the container. A system, process and use in the field of dialysis are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/304,984, filed May 29, 2009, which is a national phase of PCTApplication No. PCT/EP07/55973, filed Jun. 15, 2007, which claimspriority to Swedish Application No. SE 0601327-0, filed Jun. 15, 2006.Each of these applications are hereby incorporated by reference in theirentireties.

FIELD OF THE INVENTION

This invention pertains in general to the field of solutions,particularly medical solutions. More particularly the invention relatesto a container, a method and a system for providing a medical solution,such as a dialysis solution.

BACKGROUND

U.S. Pat. No. 6,149,294 discloses an apparatus for preparation of fluidsintended for medical use from powder. The apparatus comprises acontainer such that the water and powder can be mixed and a concentrateprovided in the container, and a recirculation circuit for recirculationof the water or concentrate solution into the container for furthermixing of the water and powder to prepare a concentrate having apredetermined concentration.

This apparatus is able to prepare a ready mixed dialysis solution orreplacement solution to be delivered to a dialysis machine performinghemodialysis (HD), hemodiafiltration (HDF) or hemofiltration (HD). Theprepared solution may as well be used for other purposes, such asperitoneal dialysis, or as nutritional solution for infusion into theblood of a patient. However, this apparatus comprises several valves andother devices requiring control by a computer. Thus, there is a need fora simpler device for preparing a medical solution.

WO 00/057833 discloses a container for enclosing a medical agentintended to be used in dialysis treatment. The container comprises anelectrolyte compartment and a power compartment. Shortly before use, thepowder compartment is opened to allow the powder to dissolve in theelectrolyte solution in the electrolyte compartment. Furthercompartments may be provided. The mixed solution is delivered via anoutlet tube for subsequent use in for example peritoneal dialysis. Theseparate compartments are interconnectable by frangible pins or by sealsthat are breakable by pulling in pull-tabs.

This container requires manual handling in order to connect thedifferent compartments to each other for blending the contents thereof.However, many patients using such medical solutions, for exampledialysis patients, have weak muscles, making such pulling in tabsdifficult to perform. Thus, there is a need for a container that can beplaced in a system, which performs the blending automatically, withoutthe need for intervention by the patient, or with minimal requirementfor muscle strength of the patient.

DISCLOSURE OF THE INVENTION

Accordingly, the present invention preferably seeks to mitigate,alleviate or eliminate one or more of the above-identified deficienciesin the art and disadvantages singly or in any combination and solves atleast the above-mentioned problems by providing a container, system,process, and use according to the appended patent claims.

According to an aspect of the invention, there is provided a containerfor enclosing a medical agent, comprising: at least one compartment (A,B, C) comprising the medical agent; an inlet connector for connection tothe compartment; at least one separator for separating the at least onecompartment from the inlet connector characterized in that the separatoris configured to open when a pressure is applied through the inletconnector.

According to another aspect of the invention, there is provided a systemfor providing a medical solution. The system comprises at least onecontainer comprising an inlet connector for receiving a fluid in acompartment therein, a fluid pump connected to the inlet connector bymeans of an inlet tube for providing liquid, such as water, from aliquid source (105) to the at least one container a first valve (95)provided between the liquid pump and the inlet connector, which isnormally opened, a second valve, which is normally closed, providedbetween the inlet connector and a solution supply reservoir, such thatin use the medical solution is prepared by mixing a contents of the atleast one container with the liquid from the liquid source.

According to yet another aspect of the invention, there is provided amethod for providing a medical solution. The method comprisesintroducing a first water volume into a container, according to any ofclaims 1-20, from a water source via a water pump and via a first valve,providing a pressure by the water pump for opening a first of the atleast one compartment dividers, stopping the water pump when thepressure is provided, re-circulating the contents of the container bymeans of a re-circulation pump with the introduced first sufficientvolume of water, thus providing a mixed medical solution, andcommunicating the mixed medical solution to a solution supply reservoir.

According to another aspect of the invention, there is provided a methodfor emptying a system according to any one of the claims 20-32. Themethod comprises: changing direction of the water pump into backwardpumping mode, changing direction of the first valve and the second valveinto backward flow mode, emptying the system of fluid by pumping thefluid into a drain.

According to another aspect of the invention, there is provided a use ofthe container according to any one of claims 1 to claim 13 in peritonealdialysis treatment, such as Continues Ambulatory Peritoneal Dialysis orContinuous Cycling Peritoneal Dialysis, Hemofiltration batch andHemodiafiltration batch.

According to yet another aspect of the invention, there is provided ause of the container according to claims 1-19 in dialysis treatment,such as Hemodialysis, Hemofiltration online and Hemodiafiltrationonline.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which the inventionis capable of will be apparent and elucidated from the followingdescription of embodiments of the present invention, reference beingmade to the accompanying drawings, in which

FIGS. 1 to 8 are schematic illustrations of containers in the form ofbags according to different embodiments;

FIGS. 9 to 13 are schematic illustrations of systems according tovarious embodiments;

FIG. 14 is an illustration of a system emptying process;

FIG. 15 is an illustration of a system disinfection process;

FIGS. 16A-C are illustrations of a bag connection adaptor according toan embodiment; and

FIGS. 17A-B are illustrations of a container in the form of a bagaccording to an embodiment.

DETAILED DESCRIPTION OF EMBODIMENTS

The following description focuses on embodiments of the presentinvention applicable to a dialysis system and in particular to thepreparation of a dialysis liquid or dialysis concentrates of differentconcentrations using powder concentrates. However, it will beappreciated that the invention is not limited to this application butmay be applied to many other liquid mixing and solution providingsystems. Thus, medical solutions prepared by the embodiments describedbelow can be used in dialysis treatments, as concentrate solutions orready-made solutions for dialysis, as infusion solutions, such asRinger's lactate, as nutrition solutions, as replacement solutions, asplasma expander solutions, etc.

FIG. 1 discloses a container, such as a bag, 10 comprising twocompartment dividers 6, which divides the bag 10 into three compartmentsA, B, and C. The compartments A-C may contain powder or liquids inamounts suitable for providing a solution, such as a dialysis, bydissolving the powder in liquid and by mixing the contents of thecompartments A-C. The bag 10 may optionally be attached to a hangerusing e.g. a hole 8 or a terminal strip, etc.

The bag 10 is provided with an inlet connector 3, connected to an inlettube 2 for introducing a fluid, such as water or a gas, into compartmentA of the bag. When the fluid enters the bag 10 through the inletconnector 3, the compartment dividers 6 are arranged to break or rupturein order to connect the compartments to each other as further describedbelow.

The first compartment divider 6′ between compartments A and B will breakwhen the fluid pressure inside the compartment A connected to the inlet3 exceeds a predetermined first pressure. Then, the first compartment Ais connected to the second compartment B and the contents thereof mayblend with each other and mix.

When the first compartment divider 6′ opens, the fluid pressure may dropdue to the increase in volume of compartment A together with compartmentB. By continued introduction of additional fluid into the bag, the fluidpressure therein increases to a predetermined second pressure so thatthe second compartment divider 6′ between compartments B and C will openand provide communication between compartment B and compartment C. Thus,a second blending and mixing of the contents of compartment C and thecontents of compartments A and B is provided.

The first and second predetermined pressures are mainly based on thedesign of the bag and the respective compartment divider. In someembodiments the first and second predetermined pressure is identical,however due to the design of the bag, in terms of stiffness in the usedmaterial and the design of the respective compartment divider, thepredetermined pressure may vary between different bags and between thefirst and second predetermined pressure within a bag. For example apredetermined pressure for a compartment divider may be 1-2 bar, such as1.5 bar. However, any other predetermined pressure may be used in orderbreak or rupture the compartment divider.

In the following the term “sufficient pressure” may be interpreted to apredetermined pressure based on the design of the bag and compartmentdivider, sufficient to break or rupture the compartment divider.

The compartment dividers may be provided in the shape of an arrow tip 21as illustrated with reference to bag 20 in FIG. 2. The largest tensionforce exerted on the compartment divider, when fluid is introduced intothe bag 20, will be localized at the tip of the arrow shape, and hence,this portion of the compartment divider 21 will open first whenincreased pressure is applied. The advantage of this embodiment is thatthe compartment divider opening process, with regard to the location inthe bag, is controlled.

Depending on the bag contents and the way of mixing the bag contents,different kinds of compartment divider shapes may be chosen. Forinstance, a straight compartment divider may be provided as shown inFIG. 1. The compartment divider may have a wave shape. The compartmentdivider may have a zig-zag shape, which may result in opening of thecompartment divider at several locations simultaneously when pressure isapplied.

The fluid used for opening the compartment divider may be water providedfrom a water source. In an embodiment, the water introduced incompartment A may be used for dissolving powder arranged in compartmentB, when the compartment divider 6′ ruptures. Additional introduction ofwater will result in that the second compartment divider 6″ betweencompartments B and C ruptures, whereby a solution or a further powderwill mix with the contents of the combined compartments A and B, therebyto provide the ready-made medical solution.

In another embodiment, the fluid used to open the compartment dividermay be a pressurized gas, such as air or nitrogen gas. In this case, thefluid does not take part in the preparation of the final solution, butis only used for opening the compartment dividers 6′ and 6″ in order tomix the contents of the compartments. In an embodiment, the lowercompartment A comprises water, while the second compartment comprises apower, which dissolves in the solution at mixing. Finally, compartment Cmay comprise a further powder, which dissolves in the solution atmixing, when the second compartment divider is ruptured.

The nitrogen may also be used to remove free radicals from the oxygennormally contained in the bag.

In an embodiment, the compartment divider is configured to open viachemical reaction or dissolution. The compartment divider may e.g. beclosed utilizing a substance, such as non-toxic glue, enabling chemicalreaction or dissolution. By introducing a chemical reagent, such aswater, into the bag e.g. via the inlet connector, a reaction of thenon-toxic glue and the chemical reagent may result in that the gluedissolves and the compartment divider opens.

In an embodiment, the compartment divider is configured to open when thecompartment divider is subjected to heating. For example, thecompartment divider may be closed using a substance, such as non-toxicheat sensitive glue, enabling thermal dissolution. Hence, by applyingheat on the compartment divider, the compartment divider may open.

In an embodiment, the compartment divider may further be a heatconducting material to improve the thermal homogeneity over thecompartment divider. For example, a thin metal foil may be used to heatthe compartment divider until it opens.

In an embodiment, the compartment divider is configured to open by meansof induction. By inducing an electromagnetic field the characteristicsof the substance used to close the compartment divider may be altered.

In some embodiments a vacuum chamber is provided, in which the bagaccording to an embodiment may be inserted. The vacuum chamber may be apart of a bag connection adaptor 160 (mentioned in greater detail below)to which the bag is connected for providing a medical solution. Thevacuum chamber may also be used to provide a mixing action of thecontents of the bag by successively creating vacuum and letting air intothe vacuum chamber. This will result in that the contents of the bag aremixed by being forced out of the bag via a bag connector, such as a baginlet connector, and into the bag again via the same or other bagconnector.

The inlet tube 2 may be remotely connected to a water source providing ametered volume by a water pump. The water to be introduced into the bagshould be of medical quality, in order to be compatible with the endproduct. For a dialysis solution, reversal osmosis water may be used.For solutions to be introduced into the blood circuit, sterile watershould be used.

The inlet tube 2 may also be connected to a re-circulation pumpproviding re-circulation of the contents of the bag.

The water introduced into the bag may be required to be carefullycontrolled as to the volume thereof. Thus, the water volume ismonitored, for example by having a metering pump. The bag may bearranged on a scale, so that the weight of the bag is monitored, andthus, the weight of water introduced into the bag.

The re-circulation pump and the water introduction pump may be acentrifugal pump or a gear pump or a peristaltic pump.

In an embodiment of a bag 30, according to FIG. 3, an inlet connector 33comprises a valve adapted to enable flow in both directions. Are-circulation pump may be connected to the inlet connector 33 and byalternating the flow of the re-circulation pump back and forth the bagis capable of mixing the contents of the bag. Suitable periods of infloware combined with suitable periods of backflow providing the mixture. Byutilizing a feeding pressure sufficient for opening the compartmentdivider, controlled mixing of the bag contents of different compartmentsis obtained.

According to an embodiment of a bag 40, according to FIG. 4, the bag 40,in comparison to the above-described bags 10, 20, 30, further comprisesan outlet connector 41 connected to an outlet tube 42. Here, the inletconnector 43 is provided with a check valve, such as a non-return valve,to prevent back flow from the bag into the inlet tube 44. The outletconnector 41 has also a check valve, such as a non-return valve, toprevent back flow from the outlet tube 42 into the bag. By connecting are-circulation pump (not shown) to the inlet tube 44 and/or outlet tube42 the bag is capable of mixing water with the contents of the bag byforcing the mixture into the bag via the inlet connector 43 and out ofthe bag via the outlet connector 41. This re-circulation processprovides effective mixing of the contents of the bag with water. There-circulation process also facilitates the dissolution of a powder inthe water, by agitating the water.

In an embodiment of a bag 50, according to FIG. 5 the inlet connectorand outlet connector are integrated, as illustrated at 51. The advantageof this embodiment is that only one penetration opening into the bag isrequired for providing and removing mixture from the bag through twodirectional access tubes 52, 53, which are provided with non-returnvalves.

A further embodiment of a bag 60 is illustrated in FIG. 6. The bag 60 issimilar to the bag illustrated in FIG. 3, and further comprises anoutlet connector 61 located in the upper compartment of the bag 60. Theoutlet connector 61 has a check valve, such as a non-return valve, toprevent back flow from the outlet tube 62 into the bag. The valve mayalso be arranged in the outlet tube 62. A re-circulation pump (notshown) connected to the inlet tube 63 performs the mixing of contents ofthe bag 60 by alternately forcing the mixture out of the bag and intothe bag via the inlet connector 64. After the mixing has been completedand a mixed solution is obtained, the mixed solution may be provided toa dialysis circuit via the outlet connector 61.

In an embodiment, the outlet connector 61 is configured with a membraneadapted for enabling penetration by means of e.g. a suction tube 1099connected to a dialysis circuit 109, see FIG. 10. The membrane may be ofa flexible plastic material. The membrane may also be made of e.g.aluminum foil or a combination of an aluminum foil and a plasticmaterial, such as polyethene etc.

In an embodiment of a bag 70, according to FIG. 7, the bag illustratedin FIG. 6 further comprises a second outlet connector 71 connected to asecond outlet tube 72. The inlet connector 73 has a non-return valve toprevent back flow from the bag into the inlet tube 72. The second outletconnector 71 has also a non-return valve to prevent back flow from thesecond outlet tube 72 into the bag. By connecting a re-circulation pump(not shown) to the inlet tube 74 and the second outlet tube 72, the bagis capable of mixing water with the contents of the bag by forcing themixture out of the bag via the second outlet connector 71 and into thebag again via the inlet connector 73. After the mixing has beencompleted and a mixed solution has been obtained, the mixed solution maybe provided to a dialysis circuit via the first outlet connector 75 inthe upper compartment of the bag.

In an embodiment the inlet connector and the second outlet connector ofFIG. 7 are integrated (as shown in FIG. 7B). The advantage of thisembodiment is that only one penetration opening into the bag isnecessary for providing and removing mixture from the bag.

Furthermore, the inlet connector and the outlet connector may beprovided as a double lumen connector 76 in FIG. 7B, wherein the inletconnector is a canula provided inside a sleeve that constitutes theoutlet connector. Conversely, the outlet connector may be provided as acanula inside the sleeve constituting the inlet connector.

A further embodiment is illustrated in FIG. 8. Here, a bag 80, which issimilar to the bag illustrated in FIG. 1, further comprises an outletconnector 81, which is connected to the upper compartment C of the bag.Moreover, the bag 80 comprises two flow distribution channels 821, 822and two pump compartments 831, 832.

The outlet connector 81 may be equipped with a non-return valve toprevent back flow from the outlet tube 84 into the bag. When water isintroduced into the bag by the inlet connector 2, the water is forcedthrough two flow distribution channels 821, 822 and into two pumpcompartments 831, 832. The pump compartments 831, 832 may be externallypressed, pushed or rolled, in order to provide an internal circulationflow e.g. by means of alternating pistons or similarly functioningmechanisms (not shown). When a mixed solution is obtained, the outlettube 84 via the outlet connector 81 is capable of transporting the mixedsolution e.g. to a dialysis circuit.

The bag 80 of FIG. 8 may be used for providing a sterile dialysis fluidfor use in CAPD, HF in batch and HDF in batch. The mixed solution, i.e.dialysis, may in this case either be directly forwarded to a patient'speritoneum (in the CAPD case) via the outlet connector 81 and outlettube 84 or be stored inside the bag until a treatment is appropriate.The advantage of this embodiment is that a home treatment patient doesnot have to transport and carry heavy and bulky dialysis fluidcontainers into his/her home. Instead, by installing a clean watersource, and connecting the water source to the bag according to FIG. 8,the treatment is facilitated, as is the burden on the patient.

The bags described herein may be manufactured from a flexible material,such as PVC or PP, providing a leak tight bag. A bio compatible ormedical grade material may be used for the bag. The material maysuitably be chosen for providing as little interaction of the bagmaterial with the contents thereof as possible. In some embodiments theflexible material comprises at least partly polyethene, polyamide,polypropene, or PET. In some embodiments a combination of differentflexible materials may be used. In an embodiment the flexible materialcomprises an outer PET layer with a thickness of approximately 120 μm toprevent humidity from entering the bag, a middle polyamide layer with athickness of approximately 15 μm to make the bag durable towardstearing, and an inner polyethene layer with a thickness of approximately12 μm for enabling welding of the bag.

According to an embodiment the non-return valve of the inlet connectorand/or outlet connector may comprise a two-welded thin flat foliodesign.

The non-return valve in the inlet connector and outlet connector may beany non-return valve, such as a non-return valve with a sliding ballmechanism.

In an embodiment, the bag may be provided with any number n ofcompartments and thus n−1 compartment dividers, such as two compartmentsand one compartment divider.

Hence, a bag with one compartment divider may be provided, wherein theupper compartment is filled with powder. An advantage of this embodimentis that the powder cannot disturb the action of a valve mechanism of theconnector to the lower compartment.

In an embodiment for providing a solution for CAPD (ContinuousAmbulatory Peritoneal Dialysis) or CCPD (Continuous Cycling PeritonealDialysis), the compartments of bag 80 may have the following contents:

Compartment A: 2000 ml of water comprising sodium chloride, sodiumlactate, calcium chloride, magnesium chloride dissolved in water.

Compartment B: Glucose powder

Compartment C: Additional glucose powder

The bag 80 is activated by the introduction of a gas, such as nitrogengas in order to rupture the compartment divider 6′ between compartmentsA and B. When the divider 6′ ruptures, the glucose powder in compartmentB falls into the water solution of compartment A and rapidly dissolvestherein. The dissolution of the powder of compartment B is facilitatedby pressing the pump areas 831 and 832 in order to agitate the solution.The bag may also be inverted back and forth in order to enabledissolution of all the powder in the compartment B. Thus, a PD solutionwith a first concentration of glucose is provided, such as 15 gram perliter. If a higher concentration of glucose is desired, such as 25 gramper liter, the gas pressure is further increased in order to rupture thesecond compartment divider 6″. The glucose powder of the thirdcompartment C is then mixed and dissolved in the water contents of thelower compartments A and B. It is noted, that the two compartmentdividers 6′ and 6″ may be opened in a single operation, by keeping ahigh gas pressure until both dividers have been ruptured.

The entire bag with its contents may be sterile, for example byautoclaving the entire bag 80 with its contents. The introduction of gasinto the bag may take place by sterile connectors and the gas may besterile, so that the final product of medical fluid is sterile.

Other sterile medical fluids may be produced in the same way, such asinfusion solutions or replacement solutions.

In an embodiment, the bag is intended for producing a concentrateintended for a dialysis treatment, such as an A-concentrate and aB-concentrate.

A bag 80 for providing an A-concentrate may have the followingcomposition:

Compartment A: Empty, but having a volume of 5 liters. The compartmentmay be folded in the transport position.

Compartment B: 1050 gram of sodium chloride, 25 gram of potassiumchloride, 45 gram of calcium chloride and 34 gram of magnesium chlorideall in powder form

Compartment C: 200 gram of water comprising 32 gram of acetic aciddissolved in the water.

An A-concentrate for a dialysis treatment is prepared by entering 5liter of water to compartment A at a pressure so that the compartmentdivider 6′ ruptures. Thus, the powder in compartment B falls down intothe water of compartment A and dissolves therein. When all powder hasbeen dissolved, a gas pressure is introduced in order to rupture thesecond compartment divider 6″ so that the acetic acid in compartment Cis added to the solution in compartment A and B. This solution should bediluted in a ratio of about 1:34. The water introduced into thecompartment A should be compatible with the intended use. RO-water issuitable for the preparation of an A-concentrate. The connectors do notneed to be sterile, but should be sufficiently disinfected.

A bag 80 for providing a B-concentrate may have the followingcomposition:

Compartment A: Empty, but having a volume of 9.5 liters. The compartmentmay be folded in the transport position.

Compartment B: 750 gram of sodium bicarbonate in powder form.

A B-concentrate for a dialysis treatment is prepared by introducingwater, such as RO-water, into the compartment A, by means of disinfectedconnectors. Water is introduced until the compartment divider betweencompartment A and B ruptures, which should be after introduction ofabout 9.5 liters of water. Then, additionally 0.5 liters of water isintroduced so that all together 10 liters of water are present in thebag. The bicarbonate powder will start to dissolve in the water. Thedissolution may be facilitated by agitating the bag, as described above.When all the powder has been dissolved, a ready-made B-concentrate hasbeen obtained which should be diluted in a ratio of about 1:20.

The inlet connector and/or the outlet connector may have a suitabledesign preventing leakage, such as an interlocking function.

In an embodiment, the bag has the capacity to be completely emptied andthus results in a minimum of waste and minimum weight. It is also muchless storage consuming than the commonly used non-flexible plasticcontainers.

If the contents of a bag are not fully used during treatment, it can beused at the next treatment.

In an embodiment the bag is made from a biodegradable material, such asa biodegradable polymer.

In an embodiment the compartment divider is a weld, which breaks whenapplying the sufficient pressure value.

According to an embodiment, the compartment divider may be a zip-lock.

In another embodiment the compartment divider is glued or similarlyattached.

In an embodiment the compartment divider is provided by an externallyattached clip closing the bag.

In an embodiment, the bag is provided with a protecting film such as asemi-transparent or non-transparent film or a protection bag (not shown)protecting the contents of the bag from e.g. sunlight, humidity, heatingetc. The protecting film may be provided on the outside of the bag 10 orbe integrated in the bag wall. The protection bag may also be providedexternally enclosing the bag 10 or may the bag and the protection bag becomprised as an integrated bag. An advantage of this embodiment is thatthe contents of the bag 10 do not degenerate to the same degree as whenno protecting film or protecting bag is provided.

In an embodiment, the interior bottom surface of the bag is incliningtowards a lowest point of the bag, when the bag is in an uprightposition.

In an embodiment, the inlet connector 3 is provided at the location ofthe lowest point.

In an embodiment, the inclined bottom surface of the bag is furtherconfigured with two additional inclined opposing surfaces, beingperpendicularly arranged with reference to the inclined bottom surface.The function of the two additional inclined opposing surfaces is todirect the contents of the bag to the lowest point of the bag, and toprovide improved mixing of the contents of the bag, as the risk thatcontents of the bag will remain at the interior walls and in theinterior edges of the bag is reduced. By providing the inlet connector 3at the lowest point and adjacent to the junction of the three inclinedsurfaces the bag is configured to significantly increase the mixingefficiency as compared when no inclined surface is provided in the bag.

In an embodiment, the bag 10 is adapted to stand without any supportwhen a fluid has been introduced into the bag, which is enabled byproviding the walls with a partly rigid plastic material. Accordingly, afluid filled bag according to this embodiment can be placed onto aplanar surface, such as a table or a floor before use.

In an embodiment, the compartment divider is integrated as a part of theinlet connector (not shown) or as a cap provided on the inlet connector.Hence, there may be no compartment divider inside the very bag, andaccordingly the bag will only comprise a single compartment. Thisembodiment is advantageous when there is only one powder in the bag,such as the B-concentrate bag mentioned above.

Recently, a new type of powder has been developed, wherein electrolytesare integrated into a powder of e.g. sodium chloride. Accordingly, inthis embodiment it will not be necessary to have a separate electrolytesolution compartment and a separate sodium chloride-powder compartment,but only one compartment comprising the combination powder. This powdermay e.g. be obtained from Tomita Pharmaceutical Corp. Ltd. Hence,according to this embodiment the definition of the expression “inletconnector” may be interpreted as an inlet connector provided either withor without a cap or integrated compartment divider.

In an embodiment, according to FIG. 9, a system 900 is provided. Thesystem comprises a bag 90, as illustrated in FIG. 5, a re-circulationpump 92, a water source 93, a water pump 94, a first valve 95, which isnormally opened, a second valve 96, which is normally closed, as well asa solution supply reservoir 97, such as a dialysis batch container. Thesystem may optionally be connected to a circuit 98, such as a dialysiscircuit.

The function of the system is to provide a mixed solution to thesolution supply reservoir 97 by mixing contents of the differentcompartments of the bag 90 with water from the water source 93. The bagis capable of being connected to the system, wherein the bag 90comprises e.g. one compartment 9B containing NaCl powder and onecompartment 9C containing concentrated electrolyte solution, whilecompartment 9A is empty. Water, such as RO-water, is introduced into thebag from the water source 93 via the water pump 94 and via the firstvalve 95, as valve 96 initially is closed. When a sufficient watervolume has been introduced into bag 90, and when the water pressureinside the accessible part of bag 90 has reached the above mentionedfirst predetermined pressure value, the first compartment divider 991opens and the NaCl powder is mixed with the introduced water anddissolved therein. At the same time as the compartment divider opens,the water pump 94 is shut off and hence no additional water isintroduced into the bag 90, giving a defined volume of water mixed withNaCl powder. Valve 95 is then closed. Alternatively, the water pumpcontinues to introduce water also after the time when the firstcompartment divider has opened, in order to introduce the predeterminedvolume of water.

Subsequently, re-circulation pump 92 is initiated to pump the mixture ofwater and NaCl powder, recirculating it into the bag via the inlet tubeand out of the bag via the outlet tube of the bag. The re-circulationpump 92 is active during a first time period until the NaCl powder iscompletely dissolved in the water. The outlet tube may be provided witha filter preventing particles of the NaCl powder from passing out of thebag, since such particles may disturb the pumping action.

The re-circulation pump 92 may then be stopped and the water pump 94starts pumping in additional water into the bag 90, by re-opening valve95. When a sufficient additional water volume has been introduced intobag 90 and when the water pressure has reached a second predeterminedpressure value, the second compartment divider 992 opens and theelectrolyte solution in compartment 9C is mixed with the NaCl solutionalready prepared. When the second compartment divider 992 opens, thewater pump 94 is shut off again, valve 95 is closed, and there-circulation pump 92 starts recirculating the mixture out of the bagvia the outlet tube and into the bag via the inlet tube.

When the electrolytes are completely mixed with the NaCl solution, thesecond valve 96 is opened, whereby the solution flows to the solutionsupply reservoir 97 by gravity.

In an embodiment, the re-circulation pump is capable of pumping theresulting, blended solution out of the bag 90 and into the solutionsupply reservoir 97. The advantages of this embodiment comprise amongothers, that the used bag may be replaced by a new bag without stoppingthe treatment process, as there is continuously sufficient remainingsolution in the solution supply reservoir for the treatment. As anexample, when there is approximately 10 min of resulting solution leftin the bag and the solution supply reservoir 97, before the solutionsupply reservoir is empty, the recirculation pump pumps the remainingresulting solution out of the bag 90 and into the solution supplyreservoir. If more resulting solution is required for the treatmentprocess, a new bag is connected. The disposal of time for preparation ofthe new bag is thus 10 min. The remaining volume may be determined by alevel sensor for determining the remaining level in solution supplyreservoir 97 (see 131 in FIG. 13 below), or alternatively by a scalegiving the weight of the bag and its remaining contents.

In an embodiment, the water pump is running continuously until thecorrect, or a sufficient amount of water has been delivered to the bag,independently of when the compartment dividers break. This is forinstance implemented by filling the bag in predetermined sufficient timeintervals from a defined water source delivering a known flow of water.Alternatively, water flow or pressure measuring sensors may be suitablyintegrated into the system.

In an embodiment, the recirculation pump 92 is running continuouslyduring a sufficient time interval, such as 5 min., as e.g. empiricalstudies can be used that have shown that the mixture is ready.

In an embodiment, the system only comprises a single pump, having bothwater pump capability and recirculation pump capability.

In an embodiment, according to FIG. 10, a system 100 is provided. Thesystem comprises two bags, a first bag 1011 and a second bag 1012 eachhaving the same contents, of the same type as illustrated in FIG. 2,respectively, a first re-circulation pump 1031, a second re-circulationpump 1032, water source 105, a water pump 106, a first valve 1071normally opened, a second valve 1072 normally closed, a third valve 1073normally opened, a fourth valve 1074 normally closed, a solution supplyreservoir 108, such as a dialysis batch container. The system mayoptionally be connected to a circuit 109, such as a dialysis circuit,e.g. via a suction tube 1099. The system functions in the same manner asthe system in FIG. 9 for each sub-system comprising bag, pump and valvesdescribed with reference to FIG. 9. However, implementing two bags inthe system allows for filling the second bag 1012 when the first bag1011 for instance is nearly empty. When the first bag 1011 is completelyempty an air detector 1021 will give a signal to automatically change tothe second bag 1012. The first bag 1011 may then be exchanged with a newone. The second bag 1012 is also equipped with an air detector 1022. Byrepeating this cycle there is always enough mixed solution available inthe solution supply reservoir 108, thus further improving usableoperation time of system 100.

The embodiment according to FIG. 10 may be used for providing a readymixed dialysis solution having a composition required for dialysistreatment. In this embodiment, bag 1011 comprises components forproducing an A-concentrate and bag 1012 comprises components forproducing a B-concentrate. After activation of the bags as describedabove, and after mixing and dissolution of the powders in thecompartments, the bags comprise concentrates having a carefullycontrolled composition. By operating pumps 1031 and 1032, which aremetering pumps, for example peristaltic pumps or piston pumps, and byoperating the pump 106 to provide RO-water, the contents of the supplyreservoir may be controlled to include a dialysis solution having acomposition suitable to be delivered to a dialyser without furtherdilution.

In a further embodiment, according to FIG. 11, a system 110 is providedcomprising four bags 111, 112, 114, 115 and two solution supplyreservoirs 113, 116. The first bag 111 and second bag 112 are connectedto the first solution supply reservoir 113. The third bag 114 and fourthbag 115 are connected to the second solution supply reservoir 116. Thissystem makes it possible to obtain both A-concentrate, e.g. in thesub-system connected to solution supply reservoir 113, andB-concentrate, e.g. in the sub-system connected to solution supplyreservoir 116, for dialysis treatment. The reservoirs 113 and 115 arethen connected to inlets for the respective concentrates of aconventional dialysis machine.

In an embodiment, according to FIG. 12, a system 120 is provided. Thesystem comprises a bag as illustrated in FIG. 7. A pump 121 is capableof pumping resulting solution into the solution supply reservoir.

In an embodiment, according to FIG. 13, a system 130 is provided. Thesystem comprises a bag as illustrated in FIG. 8.

According to an embodiment, the solution supply reservoir mayadditionally have a level sensor 131, see FIG. 13, that alerts the user,e.g. via an external device, when the solution level is too low in thesolution supply reservoir and hence a new bag must be connected to thesystem.

In an embodiment, the level sensor 131 provides information regardingthe estimated time left before the solution supply reservoir is empty.

In an embodiment, the level sensor information is presented on adisplay.

External information, such as urea concentration in the patient, may bepresented on the display.

A combination of external information and information from the levelsensor is used to calculate the amount of resulting solution requiredfor the treatment, how many bags are required, etc.

In an embodiment the water source is the same water source as isconnected to the dialysis circuit, such as a reverse osmosis plant. Inanother embodiment, the water source is sterile water obtained from bagscomprising sterile water.

In an embodiment, the system is used as stand-alone equipment and addedto an existing dialysis machine and therefore connected to an existingdialysis system. The system may be connected to the same water source asthe dialysis system, e.g. via a T-connection. Furthermore, the solutionsupply reservoir may be connected to the dialysis circuit. Since theinvention is self-supporting, it does not require any rebuilding ofexisting dialysis machines.

In an embodiment the water pump is a piston pump.

In another embodiment of the present invention the water pump is a gearpump. A gear pump may be used due to economical reasons.

System Emptying Process

With reference to FIG. 14, a system emptying process is now described.The forward direction flow of the water pump 141, such as a piston pump,is changed into backward direction flow and turned on. The two-wayreturn valves 142, 143 are opened in the direction towards the drain144. The re-circulation pump 145 is turned on, pumping out the remainingcontents of the bag. The system is thus emptied of liquid. A drain valve146 may be provided to provide communication with drain 144. Anon-return valve 147 may be arranged in the line connecting the watersource 105 to the pump 141 in order to prevent that liquid beinadvertently pumped into the water source 105.

In an embodiment the pump direction of the re-circulation pump may bechanged for facilitating the system emptying process.

Disinfection Process

By referring to FIG. 15, a system disinfection process is describedhereinafter. The disinfection process is performed after theabove-described system emptying process. The bags are removed andconnectors 151, 152 are inserted interconnecting the inlet tubes andoutlet tubes previously connected to the bags. The bags themselves maybe discarded after single use, and eventually be recycled.

The disinfection process of the system may be summarized in mainly threesteps. In the first step, a predetermined volume of clean water ispumped into the system via the water pump 153. All inlet tubes andoutlet tubes of the system and the solution supply reservoir 154 arefilled with the water. When the water volume has been reached, the waterpump 153 is turned off.

In the second step a disinfecting agent (cleaning agent), such as atablet, powder or liquid, is introduced into the system, e.g. by placingthe disinfecting agent in the solution supply reservoir. Alternatively,the disinfecting agent may be placed in the solution supply reservoirbefore the first step is performed. A disinfection tube 155 is connectedto the solution supply reservoir 154, e.g. via a lid 1551. Pump 153 isactivated to circulate the disinfecting agent in the system. There-circulation pumps 1561, 1562 are turned on pumping the water withdisinfecting agent around in a re-circulation loop until thedisinfecting agent has cleaned the entire system.

In the third step, the system is emptied as explained above and inaddition the remaining contents in the disinfection tube 155 is pumpedout via the solution supply reservoir 154 and into the drain 157.Additionally, the system may be washed with water to ensure that thereis no disinfecting agent residues left in the system before use. Thedisinfection tube 155 is removed from the solution supply reservoir 154.The system is now disinfected and ready to be used again.

In an embodiment, according to FIG. 16, the connection of the bag 60,70, 80, 161 to the system is facilitated by means of a bag connectionadaptor 160, being positioned where the bag 161 will be connected to thesystem. The bag connection adaptor 160 may comprise a first adaptor 162for connection to the inlet connector 3 of the bag. The first adaptor isat the other end 1621 e.g. connected to the water pump and/orre-circulation pump for enabling filling and mixing of the contents of aconnected bag, in accordance with the above described embodiments. Insome embodiments, the bag connection adaptor comprises a second adaptor163 for connection to the outlet connector 33, 61, 75, 81. The secondadaptor 163 may also be connected to the outlet connector 42, 53, 62, 84when provided in the bottom portion of the bag. The second adaptor 163of the bag connection adaptor may be directly connected 164 to adialysis circuit or to a solution supply reservoir. The first or secondadaptor provides for easy connection of the bag to the system. Insterilization mode, a sterilization connector (151, 152) may be providedand connected between the first 162 and second 163 adaptor to enablesterilization of the bag connection adaptor. Accordingly, using thisembodiment the connection of the bag to the system if facilitated.

In some embodiments the bag connection adaptor comprises means foropening the compartment divider of the connected bag. For example, whenthe compartment divider opens via induction, the bag connection adaptormay comprise means for providing an electromagnetic field enablingopening of the compartment divider. The bag connection adaptor mayfurthermore comprise a heating means for thermally opening thecompartment divider, vacuum means such that the compartment divider isopened by means of external applied vacuum e.g. by configuring the bagconnection adaptor with a vacuum chamber in which the bag may be placed.Furthermore, when the bag comprises handle means for mechanicallyopening the compartment divider, the bag connection adaptor may comprisea mechanical means for grabbing and pulling the bag from two oppositesides, in and outwards manner from the bag in order to open thecompartment divider.

In an embodiment, according to FIG. 17 a and b, the outlet connector171, e.g. positioned on the top of the bag, is configured with a cap172, such as a threaded cap. Optionally the bag may be connected to abag connection adaptor 160 having one connection to the inlet connector3 of the bag. FIG. 17 a illustrates the bag while the cap is stillprovided on the outlet connector, e.g. during the mixing stage of thecontents of the bag. During disinfection of a conventional dialysismachine, a suction tube 173 is placed in a can comprising liquid citricacid via a threaded cap or the like and by suction of an amount ofcitric acid from the can, the system becomes disinfected. In FIG. 17 bthe cap has been removed and the suction tube 173 is provided.Disinfection should be performed between each use, to avoidcontamination. After disinfection the suction tube(s) are parked intheir respective positions in the dialysis system to be part of thedisinfection cycle. In this embodiment the outlet connector cap isprovided on the bag, and hence the suction tube may be inserted into thebag in a similar way as for the commonly known can with liquid citricacid.

In some embodiments the cap or outlet connector is configured with athin penetrateable membrane, which may be penetrated by the suctiontube. By using a membrane, optional contaminations in the air are keptaway from the contents of the bag, as the membrane presses against theouter surface of the suction tube. In this way, the bag according tothis embodiment may replace the can comprising liquid citric acid ofprior art, improving the flexibility of the way of handling for theuser, as no heavy cans of liquid citric acid are needed. Hence, byproviding a bag of this embodiment with a citric acid powder, a mixedliquid citric acid solution is provided by means of the mixing action ofthe bag. In this way, when the disinfection sequence may e.g. be: thepowder in the bag is mixed; the cap is opened; the suction tube isplaced through the cap opening or through the membrane; the dialysissystem draws the amount of liquid citric acid depending on itsconcentration; the suction tube is removed from the bag; the cap of thebag is closed; after which the dialysis system and the dialysis machineis simultaneously disinfected.

In an embodiment the membrane is injection moulded integrally with theoutlet connector. The outlet connector may e.g. have an outer diameterof 16 mm and the membrane diameter accordingly has a diametercorresponding to the inner diameter of the outlet connector. Themembrane may be provided with a hole, e.g. with 6 mm in diameter,positioned in the centre of the membrane. The hole is provided to enablethe suction tube 171 to be inserted into the bag when the cap has beenremoved from the bag. Accordingly, the bag according to this embodimentmay be used in all existing dialysis systems utilizing a suction tube.FIG. 17 illustrates a bag having a membrane 172 for enabling a suctiontube 171 to enter the outlet connector.

There are different ways of controlling the amount of water that isintroduced into the bag. The amount of water may be controlled by avolumetric measurement, e.g. by a volumetric pump, by flow measurement,by weight measurement, by conductivity measurement, by pH measurement,by pressure to a flexible bag or by pressure to a bag located in a fixedspace. These measurement parameters (volume, flow, weight, pressure,conductivity, pH, pump re-circulation times etc.) are hereinafterreferred to as water amount parameters.

According to an embodiment a transponder device 191 is provided on thebag for communicating at least one of the above-mentioned parameters toa control device 192 as exemplified in FIG. 10 within the system and/orto an external device.

The control device and/or external device may communicate information,such as water amount parameters, received from the transponder device tothe valves, water pumps, re-circulation pumps, air detectors and levelsensors of the system. The control device and/or the external device mayoptionally communicate by two-way communication. The water amountparameters are individual for each bag design.

In an embodiment, the transponder device communicates water amountinformation directly to the re-circulation pump regarding re-circulationtimes, flow rates etc.

In an embodiment, the transponder device communicates water amountinformation directly to the water pump regarding pump flow, watervolume, forward/backward operation etc.

The control device and/or external device may also have the ability toalert by light and/or sound a patient/user of specific conditions, e.g.if the pump settings are not correctly set in reference to therequirements of the bag, the solution supply reservoir is close toempty, if a new bag has to be connected etc.

In an embodiment the control device comprises a display for displayingthe parameters such as the remaining treatment time, estimated timeuntil the bag will be empty and hence a new bag may have to beconnected, as well as the water amount parameters, ID of the bag etc. Inthis way a user/patient will have complete general overview of thetreatment process.

In an embodiment, the transponder device has a means of identificationand a communication interface to communicate this to the control devicewithin the system of the external device.

In an embodiment the outlet connector, when the outlet connector isdirectly connected to a dialysis circuit, is configured with a flowsensor. Accordingly, the out-flow of mixed solution from the bag may bemeasured. By knowing the amount of mixed fluid in the bag, the estimatedtime until the bag will empty may be calculated by the control device.Moreover the flow sensor may be used to calculate the consumption ofconcentrate, and the remaining amount of concentrate in the bag.

In some embodiments, a flow sensor is provided in an external device,such as a urea sensor, being connected (directly or indirectly) to theoutlet connector.

In some embodiments, a flow sensor is provided in the inlet connectorfor enabling measurement of inlet flow into the bag. The measurement ofthe inlet flow e.g. enables calculation of estimated time until the bagwill be empty.

Another way to determine estimated time until the bag will be empty maybe by measuring the liquid column in the bag in conjunction withinformation of the interior dimension of the bag. In some embodiments,the bag is provided with a volume level indicator along the longitudinaldirection of the bag. Accordingly, the volume left in the bag may beobserved visually. Optionally, one level scale may be used for eachdialysis flow and hence the level meter may comprise several differentscales for different outlet flows.

In an embodiment, all bags used in the system have a means ofidentification. At a dialysis fluid providing system the identificationis needed for verifying that a correct bag is attached to the system.The control device within the system or the external device manages theidentification codes allowed for a bag to be connected to the system.The means of identification may be labels equipped with bar code orPIN-code, magnetic strip, transponder or chips as means ofidentification.

Additionally, all valves, water pumps, re-circulation pumps, airdetectors and level sensors etc. of the system may have a means ofidentification.

Additionally, the user/patient may be provided with a means ofidentification, such as an ID-card with PIN-code, magnetic strip,transponder, data chips etc for the individuals, i.e. patient andoperator. In this way the control device and/or the external device mayverify that the patient ID corresponds to the bag ID and hence a correctdialysis solution is provided for the user/patient.

The water amount parameters and the means of identification in thesystem are managed by the control device within the system or by theexternal device.

In an embodiment, the transponder device on the bag provides both wateramount parameters and means of identification to the control deviceand/or external device.

The control device and/or the external device determine, given theinformation received from the transponder device, the pressure values,the water volume, time for effective mixing by re-circulation and theadditional water volume.

The present embodiments provide many advantages over the prior art. Forexample, the re-circulation process according to an embodiment of theinvention, by using re-circulation pumps, provides an automatic, safeand accurate mixing of the contents of the bag. In the case of treatmentby HD, HDF and HF using a bag according to an embodiment, no manualmixing is necessary. Hence, the present invention reduces the risk forthe patient/user of doing an error.

By applying water or gas pressure in the bag, opening of the compartmentdivider is performed automatically. Thus, the user/patient does not needto manually open different compartments of the bag. Hence, the presentinvention reduces the risk for the patient/user of doing an error.

In A-powder bag providing a solution from powder weighs prior to mixingapproximately 1.5 kg. A B-powder bag providing a solution from powderweighs prior to mixing approximately 700 grams. The embodiments cancompletely substitute liquid concentrate by providing bags with powderthat are filled with water at the point of use. Even A-powder bags areprovided, since the powder and electrolytes are placed in separatecompartments in the bag and mixed firstly at filling with water at thepoint of use. Thus, it is no longer necessary to use two bags orcartridges for providing an A-concentrate solution.

The bags according to embodiments may be used in any dialysis treatment,such as HD (e.g. for bags 10-70 illustrated in FIG. 1-7) and Peritonealdialysis (e.g. for the bag 80 shown in FIG. 8) or batch HF and HDF.

The system according to embodiments may be used as a stand-alone deviceand be added to an existing dialysis machine and therefore be connectedto an existing dialysis system just by connecting the system to a watersource and connecting the solution supply reservoir to the dialysisfluid inlet of the dialysis system.

Furthermore, the bag according to an embodiment, after use is totallyemptied, which accordingly reduces the waste and weight of the used bag.

Moreover, filling and preparation of the bag (FIG. 7) with fluids can bedone at separate stations. A home treatment patient may in this way fillseveral bags and store them until the treatment (PD, CAPD, HF batch orHDF batch) starts.

Although the present invention has been described above with referenceto specific embodiments, it is not intended to be limited to thespecific form set forth herein. Rather, the invention is limited only bythe accompanying claims and other embodiments than the specific aboveare equally possible within the scope of these appended claims, e.g.different application areas than those described above.

In the claims, the term “comprises/comprising” does not exclude thepresence of other elements or steps. Furthermore, although individuallylisted, a plurality of means, elements or method steps may beimplemented. Additionally, although individual features may be includedin different claims, these may possibly advantageously be combined, andthe inclusion in different claims does not imply that a combination offeatures is not feasible and/or advantageous. In addition, singularreferences do not exclude a plurality. The terms “a”, “an”, “first”,“second” etc do not preclude a plurality. Reference signs in the claimsare provided merely as a clarifying example and shall not be construedas limiting the scope of the claims in any way.

What is claimed is:
 1. A container for providing a medical solution,comprising: at least two compartments, wherein at least one compartmentof said two compartments includes a powder; one of said at least twocompartments is a lowest compartment configured to receive a volume ofliquid; an inlet and an outlet integrated into one double lumenconnector connected to said lowest compartment; a welded compartmentdivider arranged to separate two of said at least two compartments, saidwelded compartment divider is configured to break upon said lowestcompartment being filled through said inlet with said volume of liquid,and wherein said inlet and said outlet are configured to simultaneouslyallow an inflow through said inlet and an outflow through said outlet,thereby allowing mixing liquid with said powder by forcing said mixtureout of via said outlet and in again via the inlet.
 2. The container ofclaim 1, wherein said compartment divider is provided in the shape of anarrow tip.
 3. The container of claim 1, wherein said inlet is providedwith a valve.
 4. The container of claim 3, where is said valve is anon-return valve.
 5. The container of claim 1, wherein said outlet isprovided with a valve.
 6. The container of claim 5, where is said valveis a non-return valve.
 7. The container of claim 1, wherein said inletis connectable to a liquid pump for supplying said volume of liquidthrough said inlet.
 8. The container of claim 1, wherein said solutionincludes an electrolyte solution.
 9. The container of claim 1, whereinsaid powder is a bicarbonate powder.
 10. The container of claim 1,wherein said outlet is provided with a membrane.
 11. The containeraccording to claim 1, further comprising at least one flow distributionchannel provided inside a first compartment of the container, whereineach of said flow distribution channels has a proximal end and a distalend, said proximal ends being connected to said inlet and said distalends being connected to at least one pump compartment, wherein said pumpcompartments are configured to provide a mixing action in said containerby an external alternating press action exerted to said pumpcompartments.
 12. The container of claim 1, wherein said at least twocompartments are three compartments, said three compartments areseparated by two welded compartment dividers each one of said two weldedcompartment dividers is breakable upon said lowest compartment beingfilled through said inlet with a second volume of liquid.
 13. Thecontainer of claim 12, wherein said lowest compartment is empty andfillable with a liquid.
 14. The container of claim 12, wherein saidlowest compartment is foldable in a transport position.
 15. Thecontainer of claim 1, wherein said predefined volume of liquid is atleast 5 litres.
 16. The container of claim 1, wherein said liquid iswater from a source connectable to said inlet.
 17. The container ofclaim 1, wherein at least one of said at least two compartment includesa solution.
 18. The container of claim 1, wherein said volume of liquidis a predefined volume of liquid.
 19. The container of claim 1, whereinsaid welded compartment divider is arranged transverse to a longitudinaldirection of said container.
 20. A system for providing a medicalsolution, said system comprising: a liquid pump configured to beconnected to said inlet connector of said container of claim 1, forproviding liquid from a liquid source to said container; a solutionsupply reservoir fluidically coupled to said container; a re-circulationpump connected to said inlet connector, wherein said re-circulation pumpprovides re-circulation of the contents of said container with saidliquid provided by said liquid pump; such that, in use, the medicalsolution is prepared by mixing contents of said at least one containerwith said liquid from said liquid source.
 21. The system according toclaim 20, and further comprising a first valve positioned between saidliquid pump and said inlet connector and a second valve positionedbetween said outlet connector and said solution supply reservoir. 22.The system according to claim 20, wherein said solution supply reservoiris connectable to said container via said outlet connector and comprisesa level sensor that alerts a user when a solution level falls below apredetermined value.
 23. The system according to claim 20, and furthercomprising a control device configured to control at least one of saidliquid pump, said recirculation pump, a valve based on a liquid amountparameter, an air detector, and level sensor.
 24. A method of mixing asolution in a container having at least two compartments wherein atleast one compartment includes a powder, comprising: providing a volumeof liquid through an inlet of a double lumen connector, thereby breakinga welded compartment divider separating two of said at least twocompartments; mixing said liquid with said powder by simultaneouslyallowing an outflow through an outlet of said connector and an inflowthrough said inlet of said connector, thereby mixing said liquid withsaid powder by forcing said mixture out of said outlet and in again viasaid inlet.